Surgical Product Guide » CE Mark

GI Dynamics’ EndoBarrier non-surgical type 2 diabetes therapy receives CE mark approval

admin — Thu, 24 Dec 2009 06:46:42 +0000

GI Dynamics has announced that it has received European CE mark approval for the EndoBarrier(TM) a non-surgical therapy to treat type 2 diabetes and obesity. The CE marking certifies that a product has met EU requirements for marketing in Europe. Clinical trials involving more than 270 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner.

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Gore Wins European CE Mark Approval for Next Generation Conformable GORE TAG® Thoracic Endoprosthesis

admin — Fri, 27 Nov 2009 12:14:04 +0000

W.L. Gore and Associates (Gore) has announced that it has received European CE Mark approval for the next generation GORE TAG® Thoracic Endoprosthesis. The device is available in an expanded portfolio of sizes to meet a broad range of patient needs and was engineered to treat multiple etiologies including thoracic aortic aneurysms (TAAs), traumatic aortic transections and thoracic aortic dissections.

AtriCure AtriClip System gets CE Mark approval

admin — Fri, 09 Oct 2009 05:17:04 +0000

AtriCure Inc, a medical device company and a leader in cardiac surgical ablation systems, gas received CE Mark approval for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion System. The AtriClip System is designed to safely and effectively exclude the left atrial appendage and is being launched in Europe through a phased approach during the fourth quarter. The system was successfully utilized this week in multiple European centers during both open-heart and minimally invasive cardiac procedures.

Virtual Ports EndoGrab device receives CE Mark

admin — Fri, 21 Aug 2009 04:27:01 +0000

Virtual Ports Ltd has obtained EU CE Mark for its EndoGrab device that reduces the number of incisions (or ports) needed to perform laparoscopic surgical procedures. EndoGrab is an internally anchored, hands-free retracting device that eliminates the need for the hand-held retractor that is traditionally used during laparoscopic procedures. This would reduce scarring and some of post-surgical complications associated with abdominal incisions.

HyperBranch recieves CE Mark for NuSeal 100

admin — Fri, 24 Jul 2009 05:08:53 +0000

HyperBranch Medical Technology Inc has received a CE Mark for its NuSeal 100 dural sealant product. NuSeal 100 is used in cranial neurosurgical procedures where a water tight seal is required on the dura. NuSeal 100 is intended for direct application on the dural surfaces to provide a positive seal after suturing thereby minimizing risks associated with post-surgical CSF leaks.

Starch Medical Launches New, Bioinert Surgical Hemostats

admin — Tue, 09 Dec 2008 07:45:03 +0000

Starch Medical Inc. has announced the CE approval of its PerClot(TM) Polysaccharide Hemostatic System (PHS) and the StarFoam(TM) Absorbable Polysaccharide Hemostat. Introduction of PerClot(TM) PHS will commence this month in the European Union and other select international markets. The StarFoam(TM) Absorbable Polysaccharide Hemostat will launch during the 2nd quarter, 2009. PerClot(TM) PHS is an absorbable, surgical hemostat composed of Absorbable Modified Polymers (AMP(TM)). AMP(TM) technology incorporates sophisticated, plant-based polymer modification processes that yield biocompatible, polysaccharide particles. There is no thrombin, collagen, or other human or animal components in AMP(TM) particles.

Cryolife’s BioGlue receives CE Mark approval

admin — Tue, 09 Sep 2008 14:56:07 +0000

CryoLife Inc.‘s BioGlue Surgical Adhesive has received a CE Mark approval for its use in periosteal fixation that follows endoscopic browplasty (brow lift), a reconstructive procedure of cosmetic surgery. The product can now be marketed in the European Community (EU) by CryoLife’s partner BioForm Medical under the name “BioGlue Aesthetic(TM) Medical Adhesive. Commercial launch of BioGlue in the EU will follow after further clinical development is completed. However, the product will be available in Europe on a limited basis that will help in the evaluation and development program.

St Jude Medical receives FDA and CE Mark approval for Strada Carotid Guiding Sheath

admin — Thu, 26 Jun 2008 20:48:37 +0000

St. Jude Medical Inc.has received approval from U.S. Food and Drug Administration (FDA) and European CE Mark for its Strada Carotid Guiding Sheath. The equipment is a flexible tube available in 80 and 90 cm working lengths through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries.

DiscAssist gets CE Mark certification

admin — Wed, 12 Mar 2008 18:10:14 +0000

Mazor Surgical Technologies has received CE Mark Certification for its DiscAssist guidance and positioning system for disc replacement surgery. DiscAssist helps doctors to plan the appropriate size and placement of artificial discs in interverteberal disc replacement surgery. The company aims at filing for FDA approval in the US and expected to receive the same by the end of 2008.